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Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness (EDS) in Parkinson's Disease (HARPS1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01036139
Recruitment Status : Completed
First Posted : December 21, 2009
Last Update Posted : April 12, 2013
Sponsor:
Information provided by (Responsible Party):
Bioprojet

Tracking Information
First Submitted Date  ICMJE December 11, 2009
First Posted Date  ICMJE December 21, 2009
Last Update Posted Date April 12, 2013
Study Start Date  ICMJE December 2009
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 9, 2011)
ESS change (Epworth Sleepiness Scale) [ Time Frame: at week 12 / 52 versus baseline ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 18, 2009)
ESS change (Epworth Sleepiness Scale) [ Time Frame: at week 12 / 51 versus baseline ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 9, 2011)
Safety [ Time Frame: 12-week and 52-week ]
Any AE observed and reported during the study
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness (EDS) in Parkinson's Disease
Official Title  ICMJE A Randomized, Multicenter 12-Week Double-blind Placebo-controlled Study to Assess the Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson's Disease Followed by a 38-Week Open-label Extension Phase
Brief Summary To compare the efficacy of BF2.649 over placebo (12 week Double-Blind Phase) and assess the long term safety and the efficacy maintenance(9 months Open-Label Extension Phase) of BF2.649 in the improvement of excessive daytime sleepiness in patients diagnosed with Parkinson's Disease.
Detailed Description As measured by the change from baseline in the Epworth Scale Scores (ESS) at Week 12 and at Week 51, in patients diagnosed with EDS in Parkinson's Disease.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Parkinson's Disease
Intervention  ICMJE Drug: BF2.649 (pitolisant)
1 capsule of BF2.649 (5mg, 10mg , 20 mg) O.D
Other Name: Pitolisant
Study Arms  ICMJE
  • Experimental: BF2.649 (pitolisant)
    BF2.649 (5mg, 10 mg, 20 mg) in capsules
    Intervention: Drug: BF2.649 (pitolisant)
  • Placebo Comparator: Placebo
    Placebo of BF2.649 (5mg, 10mg, 20mg) in capsules
    Intervention: Drug: BF2.649 (pitolisant)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 11, 2013)
268
Original Estimated Enrollment  ICMJE
 (submitted: December 18, 2009)
246
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with a documented history of Parkinson's disease according to UPDRS,fluctuating and non-fluctuating patients, Hoehn and Yahr score <5;
  • stabilized on optimal antiparkinsonian treatments unmodified for 4 weeks prior to study entry;
  • presenting an Excessive Daytime Sleepiness as indicated by an ESS>or=12

Exclusion Criteria:

  • Patients with a known diagnosis of other degenerative parkinsonian syndromes (e.g. Progressive supra-nuclear palsy, multisystemic atrophy, corticobasal degenerescence, diffuse Lewy's Body dementia)
  • Patients who have shift work, chronic or occasional sleep deprivation, circadian rhythm disorders
  • Patients with a severe depression indicated by (BDI>= 16)or at suicidal risk (BDI item G>0) or depression treated for less than 8 weeks
  • Patients with a cognitive impairment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01036139
Other Study ID Numbers  ICMJE P06-10 / BF 2.649
Eudract number ( Other Identifier: 2009-013885-14 )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Bioprojet
Original Responsible Party Bioprojet : Dr Catherine Scart Grès, International Project leader
Current Study Sponsor  ICMJE Bioprojet
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Kati Gutierrez, PharmD Bioprojet
PRS Account Bioprojet
Verification Date April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP